What is Clinical Evaluation of Medical Devices?

Clinical evaluation is a systematic and scientifically justified process aimed at demonstrating that a medical device meets the safety, performance, and intended use requirements under Regulation MDR 2017/745. It is mandatory for all device classes and must be conducted in a documented, ongoing, and methodologically sound manner.

The requirements are defined in Article 61 of the MDR and Annex XIV. The manufacturer must perform clinical evaluation both before market introduction and as part of post-market surveillance (PMS). The results are documented in the Clinical Evaluation Report (CER), which forms an integral part of the technical documentation.

Sources of Clinical Data Used in Evaluation

  • Scientific literature on comparable devices,
  • Manufacturer’s own clinical investigations,
  • PMCF reports and real-world evidence,
  • Medical registries and incident databases,
  • State-of-the-art analyses and industry publications.

Importance of Clinical Evaluation in Certification

Clinical evaluation is essential for obtaining CE marking and demonstrating compliance with MDR requirements. It confirms a positive benefit-risk ratio, clinical effectiveness in real conditions, and identifies potential adverse events. For Class IIb, III, and active implantable devices, involvement of a notified body is mandatory.

Steps of Clinical Evaluation Process

  1. Defining the intended purpose and clinical indications,
  2. Literature review and identification of comparable devices,
  3. Data collection (clinical trials, PMS, registries),
  4. Assessment of compliance with GSPR (Annex I MDR),
  5. Preparation of the CER (Annex XIV MDR),
  6. Continuous updates via PMCF.

Requirements for Clinical Data

  • Objective, complete, and evidence-based,
  • Relevant to the target group and use conditions,
  • Consistent with current medical knowledge,
  • Prepared in line with MDCG guidelines (e.g., MDCG 2020-13).

Manufacturer and Clinical Team Responsibilities

The manufacturer is responsible for planning and executing the evaluation, either internally or via a CRO (Contract Research Organization). Evaluators must be experienced in clinical data analysis, familiar with MDR requirements, and capable of interpreting findings relative to GSPR compliance.

Common Mistakes and Risks in Clinical Evaluation

  • Incomplete comparative data,
  • Insufficient evidence of clinical effectiveness,
  • Lack of PMCF documentation or misinterpretation of data,
  • Non-compliant CER structure per Annex XIV MDR.

Such issues may lead to certification delays or complete rejection by the notified body.

Integration of Clinical Evaluation with Technical Documentation and PMS

The Clinical Evaluation Report (CER) must align with the technical documentation, risk analysis, and PMS/PMCF plans. An integrated process enables continuous responsiveness to new clinical data and regulatory updates.

How Pure Clinical Supports Clinical Evaluation of Medical Devices

  • Development of clinical evaluation strategies,
  • Literature reviews and comparative data selection,
  • Design and execution of clinical trials,
  • Preparation of PMCF documentation and CER reports,
  • Support during communication with notified bodies.

We assist in preparing documentation for high-risk, innovative, and active implantable devices. Our experience covers full MDR compliance and up-to-date MDCG guidelines.

FAQ

What is the difference between clinical evaluation and a clinical investigation?

A clinical evaluation is the systematic analysis of clinical data—including literature, PMS, and clinical investigations—to demonstrate a device’s safety and performance. A clinical investigation, on the other hand, is one source of this data, involving empirical testing on human participants. Not all evaluations require a dedicated clinical investigation, but all investigations must be incorporated into the Clinical Evaluation Report (CER).

How often should the Clinical Evaluation Report (CER) be updated?

The CER should be updated at least every 1–2 years, depending on the device’s risk class and findings from PMS or PMCF. For Class III devices and implants, annual updates are mandatory under MDR.

Can a clinical evaluation be based solely on literature data?

Only in exceptional cases—when full equivalence with a well-documented comparator device has been established. In most cases, MDR requires literature data to be supplemented by clinical data generated by the manufacturer.

Is clinical evaluation required after the CE certificate has been granted?

Yes. Clinical evaluation is a continuous process under MDR. After CE marking, manufacturers must conduct PMCF (Post-Market Clinical Follow-up) activities to monitor the real-world safety and performance of the device on an ongoing basis.

What are the most common clinical evaluation errors identified by notified bodies?

Common issues include poor linkage between clinical data and conclusions, insufficient data for innovative devices, flawed literature review methodology, and a lack of regular updates. Additionally, failing to document the evaluator’s qualifications can lead to CER rejection.